Regulatory Initiative

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Chapter: Pharmaceutical Engineering: Quality by Design

In recent years several regulatory agencies have indicated their desire to have Quality by Design tools adopted.


REGULATORY INITIATIVE

In recent years several regulatory agencies have indicated their desire to have Quality by Design tools adopted to justify the various processes employed in the production of a pharmaceutical product to manage risk associated with the quality of the product. Notable among these are the guidances of the U.S. Food and Drug Administration and the relevant guidances (Q8–10) of the Interna-tional Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Figure 17.1 depicts the relationships beween the ICH quality chapters and their intent to (i) use quality systems, such as process analytical technology or measurement and control of operating var-iables, in (ii) risk analyses, which establishes priority of these measurements through (iii) statistically designed experiments in product development that identifies variable parameters and acceptable variances with respect to mea-sured and monitored phenomena.

Consideration of each of these items allows process space to be defined. That is the range of input variable control that is required to minimally impact on the quality of the product and thereby ensure the uniformity and reprodu-cibility of the final product derived from the various processes employed.

Quality by design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control on the basis of sound science and quality risk management (Pharmaceutical development Annex to ICH, Q8, 2007).

Quality by Design is

·        scientific, risk-based, holistic and proactive approach to pharmaceutical development;

·        deliberate design effort from product conception through commercializa-tion; and

·        full understanding of how product attributes and process relate to product performance.



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